MISSISSAUGA, ON, Dec. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency (EMEA) for marketing authorization of nimotuzumab. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
The application for the marketing authorization for nimotuzumab was submitted to the EMEA on October 4th, 2007. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its official letter Oncoscience AG states that the withdrawal of the application was made 'because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule'.
"The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma. This analysis in no manner reflects on the overall efficacy of nimotuzumab, which already has been approved for marketing in twelve countries with efficacy demonstrated in numerous indications," said David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that Oncoscience AG withdrew its application in anticipation of a later resubmission as this application was based on a very small sample that was not prospectively studied. We note that this withdrawal is consistent with actions taken by numerous large and development stage pharmaceutical companies under similar circumstances and we believe it was the correct means for managing th
|SOURCE YM BioSciences Inc.|
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